← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K971381 # POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES (K971381) _Allegiance Healthcare Corp. · KGO · Jul 9, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K971381 ## Device Facts - **Applicant:** Allegiance Healthcare Corp. - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Jul 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended Use Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are constructed from synthetic materials. They are intended to provide an alternative to wearers and patients sensitive to natural rubber. ## Device Story Powder-Free Duraprene Sterile Synthetic Surgical Gloves are neoprene-based, sterile, powder-free gloves designed for use by operating room personnel in hospitals and healthcare facilities. They serve as a protective barrier during invasive and non-invasive surgical procedures to prevent contamination of surgical wounds. The device provides a synthetic alternative for patients and clinicians with natural rubber sensitivities. The gloves are worn by healthcare providers; they function as a physical barrier. No electronic or algorithmic components are involved. ## Clinical Evidence Bench testing only. Testing included intracutaneous reactivity, Kligman maximization sensitization, and USP mouse systemic tests, showing no irritation, sensitization, or systemic response. Physical performance met ASTM D3577-91 requirements for tensile strength, elongation, and barrier defects (AQL 1.5/2.5). Powder levels were verified below 2mg/glove using vacuum filtration and negative iodine testing. ## Technological Characteristics Material: Neoprene (synthetic). Form factor: Sterile surgical glove. Standards: ASTM D3577-91 for tensile strength and barrier defects; 21 CFR §800.20 for barrier integrity. Powder-free designation verified via vacuum filtration and iodine testing. No electronic components or software. ## Regulatory Identification A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. ## Predicate Devices - Duraprene™ Sterile Synthetic Surgical Gloves ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K971387 Image /page/0/Picture/3 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word is written in all capital letters and appears to be the logo for a company or organization. JUL - 9 1997 ## 510(k) SUMMARY K971381 | Manufacturer: | Allegiance Healthcare Corporation
Route 35 West
Eaton, Ohio 45320 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Maryalice Smith
1500 Waukegan Road, Bldg. K
McGaw Park, IL 60085 | | Telephone: | (847) 785-3322 | | Date Summary Prepared: | March, 1997 | | Product Trade Name: | Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves | | Common Name: | Surgical Glove | | Classification: | Glove, Surgical | | Predicate Devices: | Duraprene™ Sterile Synthetic Surgical Gloves | | Description: | The Duraprene Sterile Synthetic Surgical Gloves are formulated using
neoprene and offered sterile. | | Intended Use: | Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are
intended for use in sterile environments within hospitals and
other healthcare facilities. The gloves are appropriate for
use during invasive surgical procedures and non-invasive medical
procedures requiring sterility. They are intended to be worn by
operating room personnel to protect a surgical wound from
contamination. These gloves are constructed from synthetic
materials. They are intended to provide an alternative to wearers and
patients sensitive to natural rubber. | {1}------------------------------------------------ Substantial Equivalence: The Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are substantially equivalent to powdered DurapreneTM Surgical Gloves in that they provide the following characteristics: - intended use - size, configuration, packaging - made of synthetic materials - tensile strength and thickness profiles ## Summary of Testing: | Test | Result | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intracutaneous Reactivity | Glove does not elicit irritation following
intradermal injection of extracts. | | Kligman Maximization
Sensitization | Glove does not display
potential to produce skin sensitization. | | USP Mouse Systemic Test | No systemic response was observed. | | Ultimate Elongation
& Tensile Strength | Glove meets or exceeds
requirements for rubber
surgical gloves per
ASTM D3577-91. | | Barrier Defects | Glove meets or exceeds
requirements per 21 CFR
§800.20, AQL = 2.5 and
ASTM D3577-91, AQL=1.5. | | Data/Test Method | Gloves meet powder level
requirements for "Powder Free"
designation using the vacuum filtration
method plus a negative iodine test.
Results generated values below the
2mg/glove cornstarch level including | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Maryalice Smith 'Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, Illinois 60085 K971381 Re : Powder-Free Duraprene Sterile Synthetic Trade Name: Surqical Gloves Requlatory Class: I Product Code: KGO JUL - 9 1997 Dated: April 10, 1997 Received: April 14, 1997 Dear Ms. Smith: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {3}------------------------------------------------ Page 2 - Ms. Smith through 542 of the Act for devices under the Electronic chrough 542 or the not of provisions, or other Federal laws or · regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom in postantial equivalence of your device to a legally marketed predicate device results in a classification for your markets production permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on compriation and advertising of your device, please contact the office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, K. Celatnids Timo Why Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small squares. The word is in black and the background is white. Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 917.473.1500 Page 1 of 1 | Applicant: | Allegiance Healthcare Corporation | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known): | K971381 | | Device Name: | Powder-Free Duraprene TM Sterile Synthetic Surgical Gloves | | Indications For Use: | These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed to be worn by operating room personnel to | protect a surgical wound from contamination. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE | (Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |-----------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------| | 510(k) Number | K971381 | | | Prescription Use (Per 21 CFR 801.109) | or | Over-The Counter Use
✓ | --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K971381](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K971381) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com